Biofire Diagnostics, Llc: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
BioFire Joint Infection Panel Recall Summary BioFire Diagnostics is recalling specific lots of its Joint Infection Panel test kits used to detect bone and joint infections due to potential contamination that could produce false positive results. The affected kits (model numbers RFIT-ASY-0138 and RFIT-ASY-0135) were distributed nationwide across the U.S. and internationally to numerous countries. This is a Class II recall, meaning the product could cause serious health consequences but is unlikely to cause death.
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- Generic Name: BioFire Joint Infection (JI) Panel Generic Name: BioFire Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Reason
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c4594fb7-fbd3-4717-aad1-2e21da6527eb